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    • Home
    • ICS
    • Health Care Technology
    • Sterilization And Disinfection
    • Sterilization And Disinfection In General
    • ISO 18362:2016

    Codes & Standards - Purchase

    ISO 18362:2016

    Manufacture of cell-based health care products -- Control of microbial risks during processing
    SKU: iso_062244_158519 Published by ISO Publication Year 2016 1 Edition 32 pages

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    • Overview
    ISO 18362:2016 specifies the minimum requirements for, and provides guidance on, a risk-based approach for the processing of cell-based health care products (CBHPs) requiring control of viable and non-viable microbial contamination. It is applicable both to CBHPs labelled 'sterile' and to CBHPs not labelled 'sterile'. ISO 18362:2016 is not applicable to: - procurement and transport of cell-based starting material used in processing of a CBHP, - cell banking, - control of genetic material, - control of non-microbial product contamination, - in vitro diagnostics (IVDs), or - natural medicines. EXAMPLE Vitamins and minerals, herbal remedies, homoeopathic medicines, traditional medicines such as traditional Chinese medicines, probiotics, other products such as amino acids and essential fatty acids. ISO 18362:2016 does not define biosafety containment requirements. ISO 18362:2016 does not replace national or regional regulations that apply to the manufacture and quality control of a CBHP.

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